A Study Evaluating GDC-0980 Administered Once Weekly in Patients With Refractory Solid Tumors or Non-Hodgkin's Lymphoma

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This is an open-label, multicenter, Phase I study to evaluate the safety, tolerability, and pharmacokinetics of escalating oral doses of GDC-0980 administered to patients with incurable, locally advanced or metastatic solid malignancy or NHL that has progressed or failed to respond to at least one prior regimen or for which there is no standard therapy.

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Ages Eligible for Study:

18 Years and older (Adult, Senior)

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Histologically documented, incurable, locally advanced or metastatic solid malignancies, or NHL without leukemic phase, that has progressed despite standard of care therapy or for which there is no standard therapy of proven clinical benefit

A biopsy-accessible lesion from which tissue can be obtained safely

Evaluable or measurable disease per RECIST and/or the following: prostate cancer patients with non-measurable disease are eligible if they have two rising prostate-specific antigen (PSA) levels that meet the PSA Working Group criteria for progression prior to initiation of study treatment; ovarian cancer patients with non-measurable disease are eligible if they have two rising CA-125 levels greater than the ULN >= 2 weeks apart prior to initiation of study treatment.

Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at screening

Life expectancy >= 12 weeks

Adequate hematologic and organ function within 28 days before initiation of GDC-0980

Documented willingness to use an effective means of contraception for both men and women while participating in the study

For patients participating in DCE-MRI assessments: at least one metastatic lesion measuring >/= 3 cm in the liver or >/= 2 cm elsewhere (lung and mediastinum lesions are ineligible) in at least one dimension (on CT scan)

Exclusion Criteria:

Leptomeningeal disease as the only manifestation of the current malignancy

History of Type 1 or 2 diabetes mellitus requiring regular medication

Grade >=2 hypercholesterolemia or hypertriglyceridemia

Malabsorption syndrome or other condition that would interfere with enteral absorption

Known untreated malignancies of the brain or spinal cord, or treated brain metastases that are not radiographically stable for >= 3 months

Clinically significant history of liver disease, including viral or other hepatitis, current alcohol abuse, or cirrhosis

Uncontrolled ascites requiring frequent paracentesis

Known HIV infection

Any other diseases, active or controlled pulmonary dysfunction, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or renders the patients at high risk from treatment complications

Significant traumatic injury within 4 weeks of Day 1

Major surgical procedure within 4 weeks prior to initiation of GDC-0980